An Interactive Distance Solution for Stroke Rehabilitation in the Home Setting

NCT04065568 | Terminated

• 1 other identifier: DISKO/STRADA
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 2

Brief Summary

Equal access to evidence based rehabilitation in the stroke population is a challenge. Home based solutions including telerehabilitation is a promising strategy to meet these needs. However, the tools must be customized for persons with stroke and the technologies developed to serve rehabilitation purposes. The DISKO-tool was developed to enable efficient, continuous training in the home setting with health professional follow ups of training and training results after stroke via video link. The tool has in a preliminary study proved feasible and safe in different phases after stroke. The functional effect of using the DISKO-tool added to conventional rehabilitation in the home setting is yet to be explored. Thus, the aim of this study is to explore the added value of using the DISKO-tool during rehabilitation in the home setting.

Conditions

Stroke Rehabilitation

Keywords

Stroke; Rehabilitation; Medical technology

Outcome Measures

Primary Outcomes (1)

• BESTest -to assess change

  Assesses balance

  T1 (baseline, before start of intervention) T2 (after completion of the 6 week intervention) and T3 (6 months after completion of the intervention)

Secondary Outcomes (10)

• National Institute of Health Stroke Scale- to assess change

  T1 (baseline, before start of intervention) T2 (after completion of the 6 week intervention) and T3 (6 months after completion of the intervention)

• Montreal Cognitive Assessment- to assess change

  T1 (baseline, before start of intervention) T2 (after completion of the 6 week intervention) and T3 (6 months after completion of the intervention)

• Modified Ashworth Scale- to assess change

  T1 (baseline, before start of intervention) T2 (after completion of the 6 week intervention) and T3 (6 months after completion of the intervention)

• Fugle-Meyr for lower and upper extremity- to assess change

  T1 (baseline, before start of intervention) T2 (after completion of the 6 week intervention) and T3 (6 months after completion of the intervention)

• Functional Ambulation Category- to assess change

  T1 (baseline, before start of intervention) T2 (after completion of the 6 week intervention) and T3 (6 months after completion of the intervention)

Study Arms (2)

Intervention group

EXPERIMENTAL

The patient will receive conventional out patient rehabilitation after discharge to the home after stroke. In addition an individualized training program with gamified excercises for motor function will be set and followed up by clincians using video communication, as part of the DISKO-tool. Patients are instructed to train self sufficiently 5 days a week and will be supervised by the treating physiotherapist. The intervention will last for 6 weeks.

Device: DISKO-tool

Control group

NO INTERVENTION

Conventional rehabilitation in primary care after discharge to the home after stroke.

Interventions

DISKO-tool DEVICE

The training program will be based on the initial assessments of functioning and disability and the patients' performance of the test exercises. Type and number of exercises per session, level of difficulty and number of repetitions (including proportion of repetitions to the right and left side of the body) will be set. The set training program is thereafter introduced and evaluated during the first follow-up by video communication with the patients.

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• impaired motor function after stroke limiting activities of daily living but can walk indoors with or without supervision (functional ambulation category\[ \>FAC 3), can stand without support \>2 min and are able to perform a forward reach of \>12 cm in standing position,
• referred to a neuroteam for rehabilitation interventions in the home setting and/or out- patient rehabilitation at Stockholms sjukhem or Rehab Nordost Täby
• motivated to perform exercises in the home setting with the DISKO-tool and with recurrent supervision by a physiotherapist through video communication.

You may not qualify if:

• cognitive and/or speech impairment, limiting the ability to follow verbal and written training instruction or study information
• other disabling neurological disorder or other diagnosis prohibiting physical activity necessary when utilizing the DISKO tool
• impaired vision preventing orientation and reading instructions on a screen
• sufficient internet access in the home to participate in the intervention

Sponsors & Collaborators

• Danderyd Hospital: lead
• Karolinska Institutet: collaborator

Study Sites (2)

Department of Rehabilitation Medicine, Danderyd Hospital

Danderyd, Stockholm County, SE18288, Sweden

Location

Stockholms sjukhem

Stockholm, SE112 19, Sweden

Location

Related Publications (2)

• Ehn M, Hansson P, Sjolinder M, Boman IL, Folke M, Sommerfeld D, Borg J, Palmcrantz S. Users perspectives on interactive distance technology enabling home-based motor training for stroke patients. Stud Health Technol Inform. 2015;211:145-52.

  PMID: 25980861 BACKGROUND

• Palmcrantz S, Borg J, Sommerfeld D, Plantin J, Wall A, Ehn M, Sjolinder M, Boman IL. An interactive distance solution for stroke rehabilitation in the home setting - A feasibility study. Inform Health Soc Care. 2017 Sep;42(3):303-320. doi: 10.1080/17538157.2016.1253015. Epub 2016 Dec 5.

  PMID: 27918220 RESULT

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Susanne Palmcrantz, PhD

  Danderyd Hosptial

  STUDY DIRECTOR

• Jorgen Borg, Prof

  Danderyd Hospital

  STUDY DIRECTOR

• Elisabet Akesson, Assoc Prof

  Karolinska Institutet

  STUDY DIRECTOR

• Erika Franzén, Assoc Prof

  Karolinska Institutet

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Baseline and outcome will be assessed by blinded physiotherapists not involved in the intervention, who will be trained to be synchronized in the assessment procedures and to follow the same standardised protocol to assure consistency both at the Danderyd Hospital and Stockholm Sjukhem site.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A randomized controlled intervention study.

Study Record Dates

• First Submitted: April 9, 2019
• First Posted: August 22, 2019
• Study Start: April 1, 2019
• Primary Completion: November 1, 2022
• Study Completion: November 1, 2022
• Last Updated: February 13, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

SE (2)